meddevicedb.com FDA Device Reference

MODEL# 7500 SURVEYOR

K944611 Class II Traditional
Decision Date
1995-04-21
Sponsor / Applicant
Devilbiss Health Care, Inc.

Technical Specification

510(k) Submission ID K944611
Product Code MNR
Medical Specialty / Panel Anesthesiology
Regulation Citation 21 CFR 868.2375
Decision Date 1995-04-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MODEL# 7500 SURVEYOR received FDA 510(k) clearance under submission number K944611, sponsored by Devilbiss Health Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1995-04-21.

Classification & Regulation

This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.